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Medical Device Systems Engineer Jobs (NOW HIRING)

Veranex

Senior Systems Engineer

Providence, RI · On-site

$113K - $162K/yr

As a Senior Systems Engineer, you will lead systems engineering activities for medical device development programs. This role ensures user needs, clinical requirements, and regulatory guidelines are ...

Stefanini

Principal Systems Engineer

Bellevue, WA · Hybrid

Principal Systems Engineer will have a broad technical background spanning hardware, software ... Strong understanding of medical device regulations, quality systems, and data privacy regulations.

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Medical Device Systems Engineer information

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$53.5K

$127.2K

$167K

How much do medical device systems engineer jobs pay per year?

As of Jun 13, 2026, the average yearly pay for medical device systems engineer in the United States is $127,215.00, according to ZipRecruiter salary data. Most workers in this role earn between $98,000.00 and $157,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Medical Device Systems Engineer, and why are they important?

To thrive as a Medical Device Systems Engineer, you need a strong background in biomedical engineering, systems engineering principles, and regulatory knowledge, often supported by a relevant engineering degree. Familiarity with CAD software, embedded systems, FDA/ISO standards, and risk management tools is typically required. Exceptional problem-solving skills, attention to detail, and effective communication are vital soft skills for this role. These competencies ensure the safe and efficient design of medical devices that meet regulatory requirements and patient safety standards.

What is the difference between Medical Device Systems Engineer vs Medical Device Quality Engineer?

AspectMedical Device Systems EngineerMedical Device Quality Engineer
Required CredentialsBachelor's in Engineering, Systems Engineering certificationsBachelor's in Engineering, Quality Management certifications (e.g., ISO 13485)
Work EnvironmentDesign, develop, and integrate medical device systemsEnsure product quality, compliance, and risk management
Employer & Industry UsageMedical device manufacturers, R&D teamsRegulatory agencies, manufacturing firms, compliance departments
Common Search & ComparisonFocus on system integration and designFocus on quality assurance and compliance

The Medical Device Systems Engineer primarily focuses on designing and integrating medical device systems, ensuring functionality and performance. In contrast, the Medical Device Quality Engineer concentrates on maintaining product quality, regulatory compliance, and risk management. Both roles are essential in the medical device industry but serve different aspects of product development and manufacturing.

How does a Medical Device Systems Engineer typically collaborate with cross-functional teams during product development?

Medical Device Systems Engineers play a central role in coordinating with interdisciplinary teams such as mechanical, electrical, software, and quality assurance engineers, as well as regulatory and clinical experts. They are responsible for integrating various subsystems, ensuring the final device meets both technical and regulatory requirements. This often involves leading design reviews, facilitating communication between specialties, and translating user needs into system specifications. Collaboration is key, as engineers must address feedback from multiple stakeholders and ensure seamless system integration throughout the product development lifecycle.

What does a Medical Device Systems Engineer do?

A Medical Device Systems Engineer is responsible for designing, developing, and integrating complex medical devices and systems. They work closely with multidisciplinary teams to ensure that devices meet regulatory standards, are safe for patients, and function as intended. Their role often includes system architecture, requirements analysis, risk management, and verification and validation testing. They also collaborate with clinicians and regulatory bodies to ensure compliance with healthcare standards. Overall, their work is crucial in bringing innovative medical technologies from concept to market.
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What job categories do people searching Medical Device Systems Engineer jobs look for? The top searched job categories for Medical Device Systems Engineer jobs are:
Medical Device Systems Engineer jobs near you

Medical Device Systems Engineer

Associates Systems LLC

Parsippany, NJ • On-site

Other

Posted 18 days ago

Job description

ob Summary:

Highly experienced, cross-functionally skilled technical leader (electrical/software/mechanical) responsible for the system level architecture/design, implementation and verification of complex systems (e.g. defibrillators, patient monitors, ventilators) in a matrix setting.

Essential Functions:

  • Works with Project/Program management to establish and refine system level requirements for assigned new and enhanced products.

  • Leads development team in translating system level requirements into product architecture and system level design including partitioning functionality into sub-systems, creating specifications for each sub-system and documenting the interface requirements among the sub-system.

  • Ensures that new product architecture meets system level requirements, is appropriately featured, robust and adaptable enough to support product lifecycle plans and objectives.

  • Establishes performance, interface, safety, and cost specifications for each sub- system within the selected architecture in consultation with the functional design leaders. Contributes significantly to the system level risk management activities associated with assigned programs.

  • Under auspices of the Program Manager, leads efforts to allocate system functionality among electronic/software/mechanical subsystems, make hardware/software/mechanical trade-off decisions, cost/time/performance trade-off and safety decisions necessary to meet the product's clinical performance, reliability, manufacturability/serviceability, regulatory and business objectives.

  • Leads efforts during the product implementation phase to develop and refine the system level design, identify and resolve sub-system performance and interface issues, and resolve cross functional design issues that have system level impacts.

  • Leads/oversees team efforts during the subsystem integration and verification testing phases to ensure that critical sub-systems meet their individual performance, interface and system integration goals and to ensure that the fully integrated system robustly meets its performance, safety and cost requirements.

  • Responsible for documenting the system level design, operating principles and sub-system interface specifications for his/her assigned new and existing products.

  • Researches and documents the relationships between clinical requirements, architectural decisions, performance requirements and product evolution plans.

  • Provides advice and consultation to engineering teams regarding system engineering principles and system level requirements of products. Actively participates in decision making processes that involve changes to the system level design of existing products.

Skills Requirements:

  • Extensive knowledge and experience in the system level design and development of multi processor based medical instruments containing biomedical signal acquisition and processing electronics and embedded software systems.

  • Demonstrated ability to translate high level product requirements into system and sub- system level specifications and designs.

  • Demonstrated success leading engineering teams in the architecture, system level design, integration and verification of portable, battery operated, multi-processor based measuring and/or patient treatment systems.

  • Working knowledge and experience with low level analog signal acquisition, digital/microprocessor systems design, power supplies, embedded real time software development, digital signal processing, real time operating systems, Analog/digital control systems, displays, batteries, data storage and wireless communications systems.

  • Working knowledge of mechanical engineering issues and processes associated with electronics packaging, small moving mechanisms, molding, and machining processes.

  • Ability to independently analyze and evaluate electronic circuitry, software and mechanical designs using drawings, schematics, source code, technical education, and experience.

  • Thorough understanding of the product development and engineering project management processes.

  • Experience with and sensitivity to human factors issues associated with the use of medical devices.

  • Knowledge and experience developing products under FDA and European Community medical device regulations and standards.

  • Excellent verbal and written communications skills. Demonstrated success in technical decision making and people management/leadership in a matrix environment.

  • Ability to handle confidential information with discretion and skill.

  • Business acumen.

Required/Preferred Education and Experience:

  • Advanced degree in Engineering including training and experience in systems, electronics, software and mechanical engineering.

  • 10+ years' experience developing electronic hardware and embedded software systems/subsystems for complex, real time measuring instruments.

  • 7+ years' experience as a Systems Engineer, leading the architectural design and systems engineering of complex, real time medical measuring instruments.

  • Knowledge of fluid mechanics and/or past experience with ventilators/aspirators is required.

  • Project management experience and training.

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